Team Leader at United HR Solutions Pvt. Ltd.
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Officer - Regulatory Affairs - Medical Device (7-10 yrs)
Position : Regulatory Affairs Officer
Qualification : Pharmacist, Bachelor/Master in Pharmacy or Pharmaceutical Science.
Work experience : 7-10 years- experience in regulatory affairs from reputed Medical Device organization.
- Experience in handling African countries is a requirement and other Asian/Latin region desirable. Experience with medical devices would be preferable candidate for the position.
- Regulatory knowledge in handling pharmaceutical products as well as medical devices.
- Superior expertise in medical device regulations and reporting in different countries.
- Prepared and submitted Technical file applications with supporting documentation to qualify for CE marking certificate registration.
- Should possess adequate knowledge on MDD or MDR regulations and applicable standards.
- Reviewed medical device labelling and advertising materials for accuracy and completeness.
- Compiled and reviewed medical device registration data for different class of products.
- Experience of preparation and submission of CTD in different countries for ROW market.
- Experience in handling queries received from NDRA in compliance to regulatory requirement.
- Updated on various regulatory guidelines on WHO, EU, ICH and ISO standards.
- Should be energetic and passionate about work.
- Ability to maintain positive attitude when under pressure and in stressful situations.
- Good administrative skills.
- Experience in project management.
- Team player with good communication skills.
- Should be well structured and systematic.
Languages : Proficiency in English is required.
- Responsible for coordination with supplier for arranging documents timely for dossier compilation.
- Concurrent follow-up with Country Manager, Agent and NDRA for ongoing submissions.
- Responsible for preparation, review and dispatch of registration dossiers for pharmaceutical products and medical devices as per application guidelines.
- Responsible for samples dispatch and to provide information to CM and agents.
- Review of registration dossiers for Medical Devices products with labelling requirement.
- Ensure all activities related to Regulatory Affairs (RA) complies with SOPs and regulatory / customer requirements.
- Responsible for evaluation, response preparation with supporting documents from supplier to query received from NDRA within deadlines.
- Coordination with cross-functional dept. on regulatory assistance.
- Review of product layouts (labels, leaflets, SPCs) in line with regulatory guidelines pharmaceutical products and medical devices.
- Proactive and dedicated work on product registration ensuring meeting deadlines.
- To support activities within team and collaborate on the development of strategies, execution of projects and ad hoc tasks.
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